NOVUM APR- menthol spray 
NOVUM SOLUTIONS INC

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Drug Facts

Topical Burn Cream Plus Pain Relief

Active Ingredient

Menthol 0.5%

Purpose

Pain & Itch Relief

For the temporary relief of minor aches and pains of muscles and joints commonly associated with backache, arthritis, strains, bruises, and sprains.

Indications

For cooling, deep-penetrating pain relief, spray Novum APR generously on the skin around aching joints or muscle pain and allow to dry without rubbing.
Apply as often as needed.

Warnings

Not intended for use on children under 2 years old except as directed by a doctor.
Avoid contact with eyes.
For external use only.
If irritation develops and persists, discontinue use and consult a doctor.
If condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

​KEEP OUT OF REACH OF CHILDREN










KEEP OUT OF REACH OF CHILDREN

​KEEP OUT OF REACH OF CHILDREN

Directions

Apply this product topically to affected areas and allow to dry without rubbing.
Use as often as needed.
Use only as directed.

Other Information

External analgesic

Inactive Ingredients

ISOPROPYL ALCOHOL, PURIFIED WATER, METHYL SALICYLATE, EUCALYPTUS ESSENTIAL OIL, SPEARMINT ESSENTIAL OIL.

Questions or Comments

​Novum Solutions, Inc.

1585 West Sam Houston Pkwy N, #820

Houston, TX 77403

www.NovumSolutions.com

CALL 832-200-8005

FAX 713-464-6319

Label

NOVUM  APR
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69574-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SPEARMINT OIL (UNII: C3M81465G5)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69574-005-051 in 1 BOX05/19/2015
1NDC:69574-005-04118.3 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/19/2015
Labeler - NOVUM SOLUTIONS INC (044818941)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(69574-005)

Revised: 11/2023
Document Id: 093a31eb-8b66-5af7-e063-6394a90aca53
Set id: 1b869a1f-5787-4d03-a546-43a8217b2b2c
Version: 6
Effective Time: 20231103
 
NOVUM SOLUTIONS INC